Last Updated: May 12, 2026

CLINICAL TRIALS PROFILE FOR ENCORAFENIB


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All Clinical Trials for encorafenib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01777776 ↗ Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma. Terminated Array BioPharma Phase 1/Phase 2 2013-07-01 To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
NCT01820364 ↗ LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma Terminated Array BioPharma Phase 2 2013-11-01 The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.
NCT02109653 ↗ Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC Withdrawn Array BioPharma Phase 2 2015-06-01 This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.
NCT02109653 ↗ Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC Withdrawn Array Biopharma, now a wholly owned subsidiary of Pfizer Phase 2 2015-06-01 This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.
NCT02263898 ↗ Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations Withdrawn National Cancer Institute (NCI) Phase 2 2015-01-01 This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time when tumors become resistant to the drugs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for encorafenib

Condition Name

Condition Name for encorafenib
Intervention Trials
Melanoma 13
Metastatic Colorectal Cancer 9
Colorectal Cancer 9
Metastatic Melanoma 8
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Condition MeSH

Condition MeSH for encorafenib
Intervention Trials
Melanoma 31
Colorectal Neoplasms 23
Brain Neoplasms 8
Colonic Neoplasms 7
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Clinical Trial Locations for encorafenib

Trials by Country

Trials by Country for encorafenib
Location Trials
United States 179
Italy 49
Spain 44
China 41
Germany 28
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Trials by US State

Trials by US State for encorafenib
Location Trials
Texas 16
California 15
Tennessee 11
New York 11
Florida 9
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Clinical Trial Progress for encorafenib

Clinical Trial Phase

Clinical Trial Phase for encorafenib
Clinical Trial Phase Trials
PHASE4 1
PHASE2 7
Phase 4 1
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Clinical Trial Status

Clinical Trial Status for encorafenib
Clinical Trial Phase Trials
Recruiting 42
Not yet recruiting 19
Active, not recruiting 6
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Clinical Trial Sponsors for encorafenib

Sponsor Name

Sponsor Name for encorafenib
Sponsor Trials
Pfizer 20
National Cancer Institute (NCI) 14
Array BioPharma 13
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Sponsor Type

Sponsor Type for encorafenib
Sponsor Trials
Industry 89
Other 66
NIH 14
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Encorafenib Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is encorafenib and what claims drive its market?

Encorafenib (BRAF inhibitor; branded as Braftovi) is used in oncology regimens that center on BRAFV600 mutation selection and combination therapy.

Core commercial logic

  • On-label clinical differentiation in BRAFV600-driven cancers, supported by combination regimens rather than monotherapy positioning.
  • Regimen stickiness because payer coverage and prescribing patterns in BRAFV600 disease areas typically attach to established evidence packages and guideline placement (especially in colorectal cancer and melanoma).

What is the current clinical-trials landscape for encorafenib?

A complete, up-to-the-minute trials register is not available in this prompt context. No defensible, citation-backed “current status” list can be produced without a specific dataset feed (e.g., ClinicalTrials.gov export by date). Under the constraints, a partial trials summary would be noncompliant.

What markets does encorafenib address and how is demand formed?

Encorafenib demand is formed through three primary routes:

  1. Metastatic colorectal cancer (mCRC) with BRAFV600E or BRAFV600E-positive disease in line with combination regimens
  2. Metastatic melanoma with BRAFV600E/K (including combination approaches that involve MEK inhibition)
  3. Line-of-therapy and access dynamics: uptake is driven by whether the regimen is positioned as preferred or subsequent-line in local practice and whether testing infrastructure reliably identifies BRAFV600 mutations

Market unit economics drivers

  • Patient pool definition depends on mutation prevalence and test adoption.
  • Treatment duration depends on line of therapy, response depth, and discontinuation patterns.
  • Combination composition influences total regimen cost and payer controls.
  • Safety-managed use influences persistence and dose intensity.

Where does encorafenib sit in competitive context?

Encorafenib competes in BRAFi/combination oncology strategy where efficacy, tolerability, and payer acceptance determine regimen adoption. Across BRAFV600 disease areas, competitors generally include other RAF inhibitors and MEK-inhibitor combinations.

Market share outcomes are typically governed by:

  • Evidence strength of the specific encorafenib-containing regimen in the targeted setting
  • Guideline placement
  • Reimbursement breadth
  • Cross-regimen switching rates after progression
  • Brand-to-brand contracting at national and hospital group levels

How should you project encorafenib revenue under evidence, access, and competition constraints?

A defensible numerical projection requires baseline revenue (or unit sales), current geography coverage, payer dynamics, and verified trial status by indication. This prompt does not provide those inputs and there is no citation-backed dataset to ground a forecast in market numbers.

Under the constraints, the only compliant “projection” is a structural projection framework that maps what will move the curve, not a numeric forecast.

Projection framework (what will move demand)

Upside levers

  • Expanded or newly sustained regimen adoption in on-label settings where evidence supports improved outcomes
  • Improved access via formulary inclusion, managed entry agreements, or indication-specific contracting
  • Testing uptake that increases the fraction of patients correctly identified as BRAFV600 mutation-positive
  • Physician adoption driven by tolerability management and sequence-of-therapy comfort

Downside levers

  • Competitive shifts to alternative BRAFi or combination strategies
  • Price pressure via tendering, discounting, or new payer controls
  • Indication erosion if guideline or evidence rankings move away from encorafenib-containing regimens
  • Discontinuation for toxicity or dose reductions that reduce effectiveness in real-world use

Scenario shapes (qualitative)

  • Base case: demand grows at or near the rate of BRAFV600 diagnosed volumes and stays anchored to current line-of-therapy patterns
  • Upside case: additional penetration and access expansion increase the fraction of treated patients within eligible BRAFV600 populations
  • Downside case: share loss and payer restriction reduce treated fractions despite steady incidence

What is the business takeaway from the current encorafenib outlook?

Encorafenib’s market trajectory is governed by regimen adoption and access more than by pure clinical trial novelty. Near-term movement is most sensitive to:

  • How quickly BRAFV600 testing scales in routine care
  • Payer coverage stability for encorafenib-containing combinations
  • Competitive regimen contracting at the national and hospital levels
  • Sequence-of-therapy guidance that determines whether encorafenib regimens remain preferred

Key Takeaways

  • Encorafenib’s commercial profile is driven by BRAFV600 mutation-driven combination regimens rather than standalone monotherapy demand.
  • A compliant “clinical trials update” requires a verifiable, date-stamped trials dataset; none is available in this prompt context.
  • Forecasting requires baseline sales/unit data and approved indication coverage by geography; without those inputs, only a structural projection framework can be supported.
  • Market growth is primarily a function of eligible patient identification (testing), payer access, and competitive contracting.

FAQs

  1. What cancers does encorafenib target commercially?
    Encorafenib is used in BRAFV600 mutation-driven oncology settings, with major commercial demand tied to metastatic colorectal cancer and metastatic melanoma combinations.

  2. Is encorafenib usually used as monotherapy?
    In practice, encorafenib is most valuable commercially as part of combination regimens in BRAFV600 disease areas.

  3. What most affects encorafenib market growth?
    The share of patients who are correctly tested and treated for BRAFV600 disease, plus payer coverage and contracting stability.

  4. How does competition typically impact encorafenib revenue?
    Competitors affect results through regimen switching, guideline positioning, and formulary and tender-based price controls.

  5. Can a numeric market projection be produced from this prompt?
    Not in a citation-backed, defensible way because no baseline revenue, unit sales, or geography-by-indication sales data is provided.


References

[1] No cited sources were provided in the prompt, and no external dataset was supplied in this context.

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